A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ocular Safety of SCH 530348 in Subjects Participating in the Schering-Plough P04737 Study (TRA^SM-Secondary Prevention Ocular Safety Study)
Overview
- Phase
- Phase 3
- Intervention
- Vorapaxar 2.5 mg
- Conditions
- Atherosclerosis
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 258
- Primary Endpoint
- Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737) (NCT00526474).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems
Exclusion Criteria
- •The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:
- •history or evidence of age-related macular degeneration on baseline evaluation
- •history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
- •history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
- •history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
- •history or evidence of glaucoma on baseline evaluation
- •history or evidence of high intraocular pressure of \>22 mm Hg on baseline evaluation
- •evidence of center foveal thickness of \>190 µm on baseline OCT examination
- •presence of vacuoles in the retina on baseline OCT
Arms & Interventions
Vorapaxar
Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Intervention: Vorapaxar 2.5 mg
Placebo
Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)
Time Frame: Up to 12 months
Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).
Secondary Outcomes
- Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT(Baseline and 4, 8 and 12 months)
- Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline(Baseline and 4, 8 and 12 months)
- Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT(Baseline and 4, 8 and 12 months)
- Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography(Baseline and 4, 8 and 12 months)